BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3962293 · Received July 29, 2014

    Report

    Report Number
    3005477969-2014-00432
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    April 22, 2014
    Report Date
    July 28, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. PAIN, WEAKNESS OF THE LEGS AND HIP, ELEVATED COBALT AND CHROMIUM LEVELS, FLUID ACCUMULATION AROUND THE HIP, EXPOSURE TO METAL DEBRIS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441917 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HEMI HEAD, PART AND LOT NUMBERS UNKNOWN